The present invention relates to treatment of obstructive prostatism, and more particularly to an adjustable urethral catheter for treating prostatism and a method for using same.
The present invention is specifically directed to an improvement in the method and the balloon catheters disclosed in U.S. Pat. No. 4,660,560 entitled, Method for Treating Obstructive Prostatism, to Klein, which is assigned to the assignee of the present application. The teachings of U.S. Pat. No. 4,660,560 are specifically incorporated herein by reference.
Obstruction of the urinary tract due to compression of the urethra by an enlarging prostate gland results in a number of symptoms in the patient, including nocturia, frequent urination, stranguria and post-void dribbling, as well as the emotional problems of pain, discomfort and embarrassment. Generally, patients suffering from such symptomatic prostatism may pursue one of three options: Continue living with the pain and discomfort, undertake prostatectomy surgery, or receive treatment by means of a urethral catheter. Choosing the surgical procedure subjects the patient to a number of hazards, including post-operative bleeding, stricture formation at the urethra or bladder neck, incontinence, post-manipulation pain or bladder spasm, urinary infection, reactive urethral swelling causing urinary obstruction and epididymitis. Further risks include wound infection, retention of prostatic chips, retrograde ejaculation, bladder perforation, hyponatremia, intravascular hemolysis, and impotency. Additionally, simple prostatectomy requires at least 1 to 3 hours in the operating room, followed by an average of one week in the hospital, and in complicated cases, two or more weeks. About 10 to 15% of prostatectomy patients require a repeat prostatectomy and probably 10% develop strictures with long-term cost considerations.
Conversely, choosing to abstain from surgery neither alleviates the patient's pain or discomfort nor reduces the probability that more serious prostate problems will develop in the future.
The third option available, that of receiving treatment by means of a urethral catheter, has a number of advantages over the above-mentioned options. Treatment by means of a urethral catheter is disclosed in the following patents: Kealing U.S. Pat. No. 3,997,408; Gants U.S. Pat. No. 2,936,760; and Layton U.S. Pat. No 4,219,026. The present invention is directed to an improvement in the procedure and balloon catheter disclosed in Klein U.S. Pat. No. 4,660,560. In the procedure set forth in that patent, a balloon on a catheter is utilized to apply pressure against the prostate gland, forcing the gland into a position from which it can no longer restrict the urethra.
In using the method described in U.S. Pat. No. 4,660,560 it is necessary that the balloon that is utilized to dilate the prostatic urethra have an annular length and be positioned so that it exerts pressure along the entire surface of the prostate gland, and not beyond the prostate gland. If the balloon is longer than the urethra, damage to the area outside of the prostatic urethra will result when the balloon is expanded. Conversely, if the balloon is shorter than the urethra, the entire obstructed area will not be expanded and obstruction will remain. For this reason, the length of the patient's urethra which is encircled by the prostate gland must be measured, preferably with a calibrated catheter. A dilating catheter which has a dilating balloon of an annular length equal to the measured length of the patient's prostate gland must then be selected. Since the size of the prostate gland to be treated varies from patient to patient, it is necessary that an extensive stock of catheters having varying balloon lengths be kept on hand. Thus, an expanded inventory of catheters is necessary and results in the expenses associated with carrying such a large inventory.
Accordingly, a primary object of the present invention is to provide a balloon catheter which has the capability of being adjusted so that it can be aligned in the urethra to coincide with the length of the urethra surrounded by the prostate gland.
Another object of the present invention is to eliminate the need for keeping an inventory of various sized balloon catheters in order to perform the dilating procedure set forth in U.S. Pat. 4,660,560.
Still another object of the present invention is to provide a method for adjusting the balloon length in a urethral catheter.
A further object of the present invention is to provide a single catheter which can be utilized to dilate a prostate gland regardless of the size or location of the prostate gland.